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Completed

NCT Number: NCT02748057

A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)

The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5 mg.

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Key information

Conditions

Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Familial Hypercholesterolemia Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Japanese
  • Outpatient with hypercholesterolemia
  • Female participant who is of reproductive potential has to agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug
  • Will maintain a stable diet that is consistent with the Japan Atherosclerosis Society Guideline 2012 (JAS 2012) for prevention of atherosclerotic cardiovascular diseases for the duration of the study

Exclusion criteria

  • Uncontrolled hypertension (treated or untreated)
  • Uncontrolled type 1 or type 2 diabetes mellitus
  • Homozygous Familial Hypercholesterolemia or has undergone low-density lipoprotein (LDL) apheresis
  • Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
  • Has had a gastrointestinal tract bypass, or other significant intestinal malabsorption
  • History of cancer within the past 5 years (except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer)
  • Human Immunodeficiency Virus (HIV) positive
  • History of drug/alcohol abuse within the past 5 years or psychiatric illness not adequately controlled and stable on pharmacotherapy
  • Consumes more than 25 g of alcohol per day
  • Currently following an excessive weight reduction diet
  • Currently engages in a vigorous exercise regimen (e.g.; marathon training, body building training etc.) or intends to start training during the study
  • Hypersensitivity or intolerance to Ezetimibe or Rosuvastatin
  • Myopathy or rhabdomyolysis with Ezetimibe or any statin
  • Pregnant or lactating
  • Taking any other investigational drugs and/or has taken any investigational drugs within 30 days

Treatment and study plan

ezetimibe

Drug

Rosuvastatin

Drug

Primary outcomes

  1. Percentage of Participants Who Experience at Least 1 Adverse Event (AE)

    Time frame: Up to 2 weeks post last dose of study drug (up to 54 weeks)

    An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who reported at least 1 AE was summarized.

  2. Percentage of Participants Who Had Study Drug Discontinued Due to an AE

    Time frame: up to 52 weeks

    An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized.

Secondary outcomes

  1. Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)

    Time frame: Baseline (predose) and Week 52

    Blood was collected at baseline (predose) and after 52 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by beta quantification ultracentrifugation. The percentage change from baseline at Week 52 was summarized.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Phase III, Open-label, Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Patients With Hypercholesterolemia Who Have Inadequate LDL-C Control on Ezetimibe or Rosuvastatin Monotherapy

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2016
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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